The following data is part of a premarket notification filed by Puritan-bennett Ireland, Ltd. with the FDA for Nellcor Puritan Bennett 700 Series Ventilator System, And Easyneb Nebulizer.
| Device ID | K990897 |
| 510k Number | K990897 |
| Device Name: | NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PURITAN-BENNETT IRELAND, LTD. MERVUE Galway, IE |
| Contact | Robbie Walsh |
| Correspondent | Robbie Walsh PURITAN-BENNETT IRELAND, LTD. MERVUE Galway, IE |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-18 |
| Decision Date | 2000-03-15 |
| Summary: | summary |